ATTUNE 1516-40-712Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295050254), received between Jul 2, 2019 and Aug 5, 2025 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (1 report).

1 other recall cover devices cleared under the same FDA submission (K111433, K233980); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY, SO THE SURGEON PREFORMED A POLY SWAP. DOI: (B)(6) 2024, DOR: (B)(6), 2025, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 22716392 ↗
• InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. THE SURGEON PERFORMED A WASH OUT AND POLY EXCHANGE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19574864 ↗
• InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. DOI: (B)(6) 2020 DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE

  Patient problems: Unspecified Infection

  MAUDE report 18737699 ↗
• InjuryMar 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT I&D WITH POLY EXCHANGE WAS PERFORMED FOR CONFIRMED INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16629983 ↗
• InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15537089 ↗
• MalfunctionDec 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY OPERATIVE NOTES (B)(6) 2016 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED, AND DEPUY CEMENT WAS UTILIZED X2. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. ON (B)(6) 2021, THE PATIENT UNDERWENT A LEFT KNEE REVISION TO ADDRESS PAIN AND TIBIAL TRAY LOOSENING AT AN UNKNOWN INTERFACE. THE TIBIAL INSERT, TIBIAL TRAY, AND FEMORAL COMPONENT WERE REVISED. THE PATELLA COMPONENT WAS RETAINED. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS.

  Patient problems: Pain

  MAUDE report 12949820 ↗
• InjuryOct 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT THE SURGERY WITH THE INSERT IN QUESTION. AFTER THE SURGERY, INFECTION OCCURRED, AND THE INSERT WAS REMOVED AND REPLACED WITH THE NEW ONE IN THE REVISION SURGERY ON (B)(6) 2021. THE REVISION COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2021. UNKNOWN SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 12605872 ↗
• InjurySep 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RE-REVISION TC3 TIBIAL COMPONENT RIGHT. REASON FOR REVISION: INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10562374 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2017: THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. ATTUNE IMPLANTS WERE UTILIZED WITH DEPUY CEMENT X2. PATELLA WAS RESURFACED. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED. (B)(6) 2018: THE PATIENT UNDERWENT A REVISION OF THE RIGHT KNEE FOR PAIN, MILD EFFUSION, AND RADIOGRAPHIC DETECTION OF INCREASED BONE UPTAKE IN FEMUR AND TIBIA. INTRAOPERATIVELY, THE TIBIA TRAY WAS FOUND INTERNALLY ROTATED AND SURGEON NOTES IMPLIES TIBIAL TRAY LOOSE AT IMPLANT-CEMENT INTERFACE AS THE COMPONENT DISENGAGED FROM CEMENT MANTLE WITH ONE ATTEMPT WHILE LEAVING CEMENT MANTLE ADHERED TO TIBIA. NO INFECTION. PATELLA WAS NOT REVISED. ONLY THE TIBIA TRAY AND POLY INSERT WERE REPLACED. THIS IS CAPTURED ON (B)(4). (B)(6) 2018: PATIENT DIAGNOSED WITH RIGHT KNEE WOUND DEHISCENCE WITH SUPERFICIAL INFECTION. PATIENT RECEIVED IRRIGATION AND DEBRIDEMENT DUE TO INFECTION. INTRAOPERATIVELY, SURGEON FOUND ARTHROTOMY COMPLETELY INTACT AND NOT ABLE TO EXPRESS FLUID FROM ARTHROTOMY ITSELF. NO IMPLANTS REMOVED AT THIS PROCEDURE. (B)(6) 2018: PATIENT DIAGNOSED WITH INFECTED RIGHT KNEE ARTHROPLASTY AND RECEIVES RESECTION OF RIGHT KNEE ARTHROPLASTY WITH PLACEMENT OF DYNAMIC SPACER. PATIENT RECEIVED A COMPLETE

  Patient problems: No Code Available; Unspecified Infection; Wound Dehiscence

  MAUDE report 9545627 ↗
• InjuryNov 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD 17 JUNE 2019. THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO INSTABILITY, DECREASED RANGE OF MOTION, AND WEAKNESS. THE SURGEON INDICATED ALL COMPONENTS WERE WELL-FIXED. THE PATELLA COMPONENT WAS NOT REVISED. COMPETITOR CEMENT WAS USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2017. DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available; Weakness

  MAUDE report 9278600 ↗
• InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN AND INSTABILITY. ORIG SURGERY WAS (B)(6) 2016. 1ST REVISION DONE (B)(6) 2017 (INSERT ONLY WAS REPLACED). DOI: (B)(6) 2017 (INSERT) (B)(6) 2016; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: Joint Disorder; No Code Available; Pain

  MAUDE report 8951822 ↗
• InjuryJul 2, 2019Naturally Worn; Naturally Worn

  MEDICAL RECORDS ALLEGES SYNOVITIS.

  Patient problems: No Code Available; Pain; Synovitis

  MAUDE report 8753358 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111433, K233980. One submission often covers many models, so check the product and lot details in each record.

• Z-1267-2023 · Feb 15, 2023 · Open, Classified
  Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507